Senior Manager, Quality & Regulatory Systems (Hybrid)

Job Title: Senior Manager – Quality & Regulatory Systems

Manager/Supervisor: Sr. Director, Information Technology

FLSA Status: Exempt

Position overview:                

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

The Sr. Manager of IT for Quality & Regulatory Systems is a key member of Insulet’s Corporate Applications team, responsible for leading the strategic planning, implementation, and management of global systems that support Quality Assurance and Regulatory Affairs. This role ensures technology solutions are aligned with business objectives, compliant with regulatory standards, and scalable to support Insulet’s continued growth and global expansion.

The Sr. Manger will oversee a portfolio of validated applications, manage a high-performing global team, and collaborate cross-functionally with internal stakeholders and external partners to deliver innovative, efficient, and compliant systems. This role is instrumental in driving digital transformation across regulated business processes and enhancing operational excellence. As Insulet continues to grow our product range and expand into new geographies it is likely that current systems will be upgraded or replaced to support the strategic goals. The Senior Manager, IT Quality and Regulatory Systems will play a key role in building our teams to support these initiatives as well as participate in vendor selection and implementation of new technologies as we evolve

JOB / DUTIES / RESPONSIBILITIES

• Oversee the lifecycle of validated systems including QMS platforms (e.g:Veeva systems, eDHR, content management, and labeling tools)
• Lead planning, execution, and governance of programs and projects, ensuring timely delivery and compliance
• Manage risk, scope, and change across initiatives to maintain alignment with business goals

• Team Leadership & Development

• Lead and mentor a global team of managers and professionals, fostering a culture of accountability, collaboration, and continuous improvement
• Drive performance through coaching, feedback, and professional development
• Promote cross-functional teamwork and knowledge sharing across IT and business units
• Recruit, interview, hire, and onboard new staff in the department. Provide constructive and timely performance evaluations. Handle discipline and termination of employees in accordance with company policy.

• Performance & Compliance

• Develop and manage KPIs, scorecards, and performance analytics to drive operational efficiency and continuous improvement
• Ensure systems meet FDA, SOX, and other regulatory requirements, maintaining validated states and audit readiness
• Champion best practices in system design, governance, and delivery methodologies (Agile, Scrum, Kanban, Waterfall)

• Stakeholder & Vendor Engagement

• Build trust-based relationships with business partners through active listening and strategic alignment
• Manage vendor relationships, contracts, and third-party consultants to ensure quality and value
• Support IT intake processes and collaborate with Enterprise Architecture, Procurement, and Agile Delivery Office

• Global Collaboration & Innovation

• Work with global process owners to develop scalable, region-specific solutions
• Evaluate third-party tools for feasibility and business impact
• Contribute to product roadmaps and support geographic expansion strategies

• Financial Oversight

• Contribute to long-range planning and resource forecasting at the program level

Skills/Experience:  

• Bachelor's degree, or equivalent experience
• 10+ years of experience in the field including 5+ years supporting/managing QMS systems in the regulated environments
• Work closely with BPOs, technical leads, architects, and development teams to ensure that platforms are designed with scale and operability in mind
• Troubleshoot and debug complex issues in production applications
• Ability to analyze business processes, design process improvements, and train business users on the new processes.
• Ability to work independently & on multiple projects against deadlines.
• Communicate effectively with people at all levels of the organization
• Experience with software development life cycle (SDLC)